bepotastine besilate ophthalmic solution 1.5%

Generic: bepotastine besilate ophthalmic solution 1.5%

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bepotastine besilate ophthalmic solution 1.5%
Generic Name bepotastine besilate ophthalmic solution 1.5%
Labeler alembic pharmaceuticals limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

bepotastine besilate 15 mg/mL

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-598
Product ID 46708-598_de111d74-c740-47b3-adc7-4b855df2c561
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214588
Listing Expiration 2026-12-31
Marketing Start 2023-04-05

Pharmacologic Class

Classes
histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708598
Hyphenated Format 46708-598

Supplemental Identifiers

RxCUI
863038
UNII
6W18MO1QR3

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name bepotastine besilate ophthalmic solution 1.5% (source: ndc)
Generic Name bepotastine besilate ophthalmic solution 1.5% (source: ndc)
Application Number ANDA214588 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 15 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (46708-598-05) / 5 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (46708-598-10) / 10 mL in 1 BOTTLE
source: ndc

Packages (2)

46708-598-05 1 BOTTLE in 1 CARTON (46708-598-05) / 5 mL in 1 BOTTLE 46708-598-10 1 BOTTLE in 1 CARTON (46708-598-10) / 10 mL in 1 BOTTLE

Ingredients (1)

bepotastine besilate (15 mg/mL)

Linked Drug Pages (1)

Bepotastine Besilate Ophthalmic Solution 1.5% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "de111d74-c740-47b3-adc7-4b855df2c561", "openfda": {"unii": ["6W18MO1QR3"], "rxcui": ["863038"], "spl_set_id": ["de111d74-c740-47b3-adc7-4b855df2c561"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (46708-598-05)  / 5 mL in 1 BOTTLE", "package_ndc": "46708-598-05", "marketing_start_date": "20230718"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (46708-598-10)  / 10 mL in 1 BOTTLE", "package_ndc": "46708-598-10", "marketing_start_date": "20230405"}], "brand_name": "Bepotastine Besilate Ophthalmic Solution 1.5%", "product_id": "46708-598_de111d74-c740-47b3-adc7-4b855df2c561", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "46708-598", "generic_name": "Bepotastine Besilate Ophthalmic Solution 1.5%", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bepotastine Besilate Ophthalmic Solution 1.5%", "active_ingredients": [{"name": "BEPOTASTINE BESILATE", "strength": "15 mg/mL"}], "application_number": "ANDA214588", "marketing_category": "ANDA", "marketing_start_date": "20230405", "listing_expiration_date": "20261231"}